Frequently asked questions about reporting adverse reactions

You shall not submit the case again to the EudraVigilance database. By doing so you will create a duplicate, making extra work for the EMA and the national authority.

22 Sep 2020

The report shall not be submitted to the other MAHs. After you have sent the report to the EudraVigilance database the MAHs B+C will identify the reports in the EudraVigilance database concerning their products and enter those into their own databases.

MAHs B+C shall not submit the report again to the EudraVigilance database.

24 Jan 2018

All the E2B fields are entered as numeric codes and the decodes appear in English. Only the narrative - the description of the ADR - is entered in the language in which it was reported to Fimea (Finnish, Swedish, English).

The MAHs are encouraged to submit to the EudraVigilance database the information on the medication and the reported ADR terms in as much detail as possible, including the reaction as reported in the original language.

24 Jan 2018, updated 13 June 2023

The access rights of the MAH are described in the document European Medicines Agency policy on access to EudraVigilance data for medicinal products for human use (EudraVigilance Access Policy) (PDF).

The answer to this question can be found in Annex C of the document: Access to the ICSR data set Level 2B under the policy.

24 Jan 2018, updated 13 June 2023

These articles need not be sent to Fimea. If necessary, Fimea will request the article.

24 Jan 2018

In order to identify a duplicate the MAH may, if necessary, contact Fimea ([email protected]). Likewise, Fimea may contact the MAH if it suspects the existence of a duplicate report. If existence of a duplicate report is confirmed, it will be agreed between the parties which one will send the information to the EMA (EMA Service Desk (ServiceNow)) and the EMA will create a ‘master case’ to the EudraVigilance database.

22 Sep 2020, updated 13 June 2023

In such situations, the MAH should contact Fimea ([email protected]) and the procedure will be agreed on a case-by-case basis.

30 Sep 2020

The procedure regarding follow-up information is as described in GVP module VI* chapter VI.C.2.2. Responsibilities of the marketing authorisation holder in the EU:

“For the ICSRs made accessible to a marketing authorisation holder from the EudraVigilance database in accordance with Article 24(2) of Regulation (EC) No 726/2004 and in line with the EudraVigilance Access Policy for Medicines for Human Use24, the routine request for follow-up by the marketing authorisation holder is not foreseen. If the follow-up of an ICSR is necessary for a specific situation, a justification should be provided with the request, which should be addressed directly to the sender organisation of the ICSR.”

*Guideline on good pharmacovigilance practices (GVP) Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev 2)

Fimea will assess the need for follow-up information for each ICSR, and contact the reporter if needed. The MAH shall not routinely ask for follow-up information via Fimea. In situations listed below no follow-up information is routinely requested from the reporter, unless assessed necessary:

• information that has already been requested on the initial report form (for example symptoms and/or diagnosis, test results, and medical history)
• medical confirmation for consumer reports
• follow-up information which is presumably not available to the reporter (for example laboratory test results for a case reported by a pharmacist)

22 Sep 2020, updated 13 June 2023

All the information on the patient and the reporter that is available and can be entered into the EudraVigilance database shall be submitted.

The details provided on an adverse drug reaction (ADR) report are confidential. They include personal data on the reporter and the patient. The disclosure of information and content of a report are based on a specific legal provision.

According to Section 30e(2) of the Medicines Act (395/1987), the marketing authorisation holder, parallel import authorisation holder or registration holder shall, as a guarantee of pharmacovigilance and patient safety on the part of the register holder, record in the ADR database all the necessary details concerning both identified and suspected adverse reactions, essential details concerning the medical conditions of the user of the medicine or person’s propensity to them, all medications, their therapeutic indications, adverse reactions to medicines, and the information required to identify the user of the medicine, such as name and personal ID, if available. According to Section 30f of the Medicines Act (395/1987), the information concerning the suspected adverse reactions to medicines should be reported to the EudraVigilance database.

There are no EU provisions on the precise content of an adverse reaction report. National provisions therefore apply. What is provided in Section 30e of the Medicines Act concerning the content of an ADR report shall also apply when reporting to the EudraVigilance database. Section 30e of the Medicines Act does not lay down any restrictions as regards the disclosure of information identifying the patient or the reporter. There are no restrictions either in the other provisions in the Medicines Act concerning ADR reporting.

24 Jan 2018, updated 13 June 2023